Precision™ SC-1110-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 6,519 adverse event reports that list this exact device (DI 08714729767688), received between Nov 26, 2012 and Sep 29, 2026 — classified as 26 deaths, 5,943 injuries, 550 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (2,846 reports).

17 other recalls cover devices cleared under the same FDA submission (P030017); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 6,519 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933792 ↗
• InjurySep 25, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899098 ↗
• InjurySep 24, 2026Charging Problem

  It was reported that the patient was experiencing frequent Implantable Pulse Generator (IPG) charging. The patient underwent an IPG replacement procedure and was doing well postoperatively. The explanted device was not returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50878499 ↗
• InjurySep 22, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862914 ↗
• InjurySep 22, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862906 ↗
• InjurySep 22, 2026Unexpected Therapeutic Results

  It was reported that the patient felt stimulation and burning sensation all around the body. The patient noted that they are supposed to feel stimulation at the back. The patient underwent an Implantable Pulse Generator (IPG) explant procedure.

  Patient problems: Burning Sensation; Inappropriate Device Stimulation of Tissue

  MAUDE report 50858098 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Pulse Generator (IPG) was no longer functioning as intended. The patient underwent an Implantable Pulse Generator (IPG) replacement procedure and was doing well postoperatively. The explanted device was not returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50851442 ↗
• InjurySep 21, 2026Fracture; Nonstandard Device; Use of Device Problem

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848926 ↗
• InjurySep 21, 2026Nonstandard Device

  It was reported that the patient underwent a Spinal Cord Stimulator (SCS) explant procedure due to device never worked as intended. No further information has been obtained despite good faith efforts.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846483 ↗
• InjurySep 21, 2026Charging Problem

  It was reported that the patient's implanted pulse generator (IPG) was unable to charge. The patient subsequently underwent a surgical procedure. During the procedure, following incision at the battery site, a white discharge was observed, and wound irrigation specimens were obtained. The midline incision was also opened, no discharge was noted at that location. However, the physician observed granulation tissue beneath the currently implanted paddle lead. Given these findings, the physician elected not to implant new equipment and instead explanted the existing system. The physician reportedly did not believe the probable infection was device related and instead suspected an underlying inflammatory condition. Culture was obtained and the result was not yet available.

  Patient problems: Fluid Discharge; Inflammation; Unspecified Infection

  MAUDE report 50841698 ↗
• DeathSep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a spinal cord stimulation (SCS) system passed away. The cause of death is unknown. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831205 ↗
• InjurySep 18, 2026Overheating of Device; Unexpected Therapeutic Results

  Patient problems: Burning Sensation; Fall; Pain

  MAUDE report 50831158 ↗
• InjurySep 18, 2026Battery Problem

  It was reported that the patient's IPG had reached End of Life. The patient underwent a procedure wherein the implantable pulse generator (IPG) and spinal cord stimulator (SCS) leads were explanted. The explanted devices were discarded by the medical facility and will not be returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817245 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Stroke/CVA

  MAUDE report 50812339 ↗
• DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a spinal cord stimulation (SCS) patient passed away. According to the available information, the death was attributed to natural causes; however, the exact cause of death has not been confirmed and it is not known by the physicians office. No additional information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805167 ↗
• DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the spinal cord stimulation (SCS) patient passed away. The cause of death is not believed to be related to stimulation; however, it remains unconfirmed. Physicians office does not have a record of patient passing away. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803186 ↗
• InjurySep 17, 2026Nonstandard Device

  It was reported that the Implantable Pulse Generator (IPG) was no longer functioning as intended. The patient underwent an Implantable Pulse Generator (IPG) explant procedure. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797840 ↗
• InjurySep 16, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50795990 ↗
• InjurySep 16, 2026Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Wireless Communication Problem

  It was reported that the patient has difficulty connecting remote control to SCS. It was noted that the patients implantable pulse generator (IPG) was no longer functioning as intended. The patient underwent a spinal cord stimulation (SCS) system replacement procedure. During the revision the physician noticed fraying of the paddle lead. The patient was doing well postoperatively. The explanted device components were kept by the facility.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789020 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was experiencing pain and discomfort. The patient underwent Implantable Pulse Generator (IPG) explant procedure. Patient was doing well postoperatively. Explanted device not available for return, the facility disposed of it.

  Patient problems: Discomfort; Pain

  MAUDE report 50786404 ↗
• InjurySep 10, 2026Nonstandard Device

  It was reported that the Implantable Pulse Generator (IPG) was no longer functioning as intended after receiving the end of life message. The patient underwent a spinal cord stimulation (SCS) system replacement procedure and was doing well postoperatively. The explanted device was components will not be return per facility policy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716537 ↗
• DeathSep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a spinal cord stimulation (SCS) system passed away. The cause of death is unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602373 ↗
• InjurySep 3, 2026Unexpected Therapeutic Results; Migration

  Patient problems: Pain

  MAUDE report 50599416 ↗
• InjuryAug 28, 2026Wireless Communication Problem

  It was reported that the remote control kept on disconnecting from the device after a few minutes and patient does not like to feel the stimulation. The patient underwent an Implantable Pulse Generator (IPG) replacement procedure and was doing well post operatively. No other information could be obtained.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50506265 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this Spinal Cord Stimulation (SCS) device was explanted due to an unknown reason. The location of the device is unknown. Information is unavailable per customer account.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50421700 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030017. One submission often covers many models, so check the product and lot details in each record.

• Z-2879-2026 · Jun 17, 2026 · Open, Classified
  INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spin
• Z-2404-2026 · Apr 29, 2026 · Open, Classified
  Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
• Z-2617-2024 · Jul 17, 2024 · Open, Classified
  WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
• Z-2119-2020 · Apr 24, 2019 · Terminated
  ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left
• Z-2124-2020 · Apr 24, 2019 · Terminated
  Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Gene
• Z-2120-2020 · Apr 24, 2019 · Terminated
  Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Devic
• Z-2123-2020 · Apr 24, 2019 · Terminated
  Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in
• Z-2121-2020 · Apr 24, 2019 · Terminated
  LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electric
• Z-2122-2020 · Apr 24, 2019 · Terminated
  The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic i
• Z-1409-2010 · Mar 19, 2010 · Terminated
  Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4
• Z-0271-2009 · Sep 22, 2008 · Terminated
  Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System labeled as BIONICS SCS-CHARGING KIT CONTENTS Charger (1) Base Station (1) Belt Po
• Z-1441-2012 · Apr 22, 2008 · Terminated
  OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractabl
• Z-0960-2008 · Oct 5, 2007 · Terminated
  Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number: SC-1110 with firmware version prior to Revision 3.02, Advanced Bionics Corportation, Sylmar, CA 91342
• Z-0055-2008 · Aug 3, 2007 · Terminated
  Precision Implantable Pulse Generator (IPG), Model Number SC-110
• Z-0700-2007 · Jan 30, 2007 · Terminated
  The Precision Implantable Pulse Generator, Model Number SC-1110

…and 2 more.